Kornimate/medical-research-clean huggingface dataset:
chronic venous insufficiency and balneotherapy

Conditions: Venous Insufficiency (Chronic)(Peripheral)

Summary: the aim of this clinical trial is to assess the efficacy of the balneotherapy program (therapeutic orientation: phlebology) in terms of chronic venous disease improvement and related quality of life, in patients presented with advanced chronic venous insufficiency (i.e., with c4-c5 of severity classification). the multicenter randomized controlled trial (rct) "thermes \& veines" that aimed at evaluating balneotherapy in patients with advanced chronic venous insufficiency is considered as the reference study. the french national academy of medicine encourages the re-use of data of published rct when available. in this context, the current study is designed as a single-arm prospective study with indirect comparison using propension score. the control group consists of the 197 patients which were allocated to the control group of the "thermes \& veines". all patients enrolled in the current study benefit of 18-days of spa treatment with mineral water of royat, and examination with vascular practitioner at enrollment and 6 months after the beginning of spa treatment.

chronic vascular disease (cvd) related quality of life and symptoms, as well as skin trophic changes from baseline are assessed at 6 months. variations from baseline are compared in control and spa treatment groups. the indirect comparison methodology is based on the reuse of individual data from a "control" group and adjustment after calculating the propensity score.

Eligibility criteria:
inclusion criteria: * primary or post-thrombotic cvd with confirmed diagnosis by by duplex ultrasound examination (last available exam); * with cvi classified as c4a, c4b, or c5) * available for balneotherapy program within the 2 next months * with health insurance affiliation. exclusion criteria: * active venous thrombosis, recent or ongoing erysipelas, peripheral arterial pathology (ankle brachial index \< 0.70). * walking difficulty * neurologic diseases of the lower limbs * presenting or likely to present a contraindication to thermal treatments, with planned surgery; * having already benefited from a thermal treatment whatever the indication during the last 6 months * chronic infectious disease, cancer, heart, kidney or liver failure; * pregnant, breastfeeding women or women planning a pregnancy within the year; * persons deprived of their liberty or subject to psychiatric care or subject to a measure of legal protection or unable to express their consent; * patient likely to not respect the protocol or not to be able to attend the visits, particularly given the study follow-up; * living at more than 30 minutes from the thermal site or who cannot be accommodated less than 30 minutes from the thermal site; * already included in a clinical trial or in the exclusion period of a clinical trial.

Keywords: spa therapy, balneotherapy chronic venous insufficiency cvi cvd
conjugated linoleic acid on body weight and body fat mass for 12 weeks

Conditions: Overweight and Obesity; Body Weight

Summary: this study has purpose to assess the effect of conjugated linoleic acid (cla)-fortified milk powder with nutrition counseling and nutrition module in body weight and body fat mass among overweight and obese adult in indonesia

after being informed of the potential benefits and risks regarding the study, the respondents were asked to sign the consent. the respondents who met the criteria of overweight/ obese without any historical diseases will be randomized into intervention or placebo groups. the intervention will be given for 12 weeks (cla-fortified milk powder 3.4 gram, once-daily consumption). both the intervention and placebo groups will also receive nutrition counseling and nutrition module.

Eligibility criteria:
inclusion criteria: 1. body mass index (bmi) 23 - 24.9 kg/m2 for overweight and ≥ 25 kg/m2 for obese 2. fat mass percentage (fm%) of ≥ 20% for men and ≥ 30% for women 3. agree to follow the study exclusion criteria: 1. lactose intolerance 2. undergoing treatment (e.g., antibiotics and/or anti-inflammatory or immunosuppressant drugs and weight loss) 3. any physical condition that might be contraindicated to dietary restrictions 4. any non-communicable disease (e.g., diabetes mellitus, chronic kidney disease, cancer, hypertension) 5. pregnant

Keywords: conjugated linoleic acid body fat mass body composition nutrition counseling
phase 1 single and multiple dose study of fpa008 in healthy volunteers and rheumatoid arthritis subjects

Conditions: Healthy; Rheumatoid Arthritis

Summary: this is a phase 1, randomized, double-blind, placebo-controlled study designed in 3 parts to assess the safety, tolerability, and pk of single and multiple ascending doses of fpa008 in adult healthy volunteers (parts 1 and 2) and adult subjects with active ra (part 3).

approximately 56 healthy volunteers will be enrolled at 1 study center in the netherlands for parts 1 and 2, and approximately 39 subjects will be enrolled at up to 6 sites in central and eastern europe for part 3. dose escalations in parts 1 and 2 will be driven by an assessment of the safety profile. review of safety and pk parameters may inform decisions to add cohorts with intermediate dose levels in order to reach an optimal target exposure.

Eligibility criteria:
inclusion criteria: part 1 and 2: * healthy adult male and female subjects between the ages of 21-55 years inclusive. * subject must be willing to remain in the clinical research unit (cru) for a minimum of 72 hours after each dose. part 3: * ra male and female subjects between the ages of 21-70 years inclusive * evidence of active ra disease * inadequate response to biologic or non-biologic dmards * subjects will be required to be on background therapy with methotrexate. exclusion criteria: parts 1, 2 and 3: * bmi \ 32 kg/m2 * clinically significant findings in physical exams and laboratory tests at screening and/or baseline * unwilling to abstain from alcohol for 48 hours prior to study start, during cru confinement, as applicable, and for 48 hours prior to study visits. * unwilling to abstain from exercise more strenuous than walking during cru confinement, as applicable, and for 48 hours prior to study visits. parts 1 and 2: * use of any prescription, non-prescription, or herbal medications as well as supplements or vitamins within 4 weeks prior to dosing, unless approved by the investigator. * smoking more than 10 cigarettes, or the equivalent, per day. part 3: * current or previous history of inflammatory joint disease other than ra * evidence of extra-articular ra disease or systemic involvement * currently taking any medications other than those allowed per protocol guidelines * any surgical procedure including bone or joint surgery within 12 weeks prior to dosing * use of intra-articular (ia), intramuscular (im), or iv corticosteroids for ra * neuropathies and neurovasculopathies * concomitant use of statins while on study.
the medtronic transcatheter aortic valve implant system (corevalve system family) post marketing surveillance (pms) (corevalve india pms)

Conditions: Symptomatic Aortic Stenosis

Summary: the medtronic transcatheter aortic valve implant system (corevalve system family) has been demonstrated to be safe and effective for high through extreme risk patients with symptomatic severe native aortic stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure. per dcgi systematic post marketing surveillance requirement, the purpose of this pms plan is to provide local post marketing surveillance data regarding the safety of medtronic corevalve system family

the objective of this pms will be to monitor and gather data on the safety of the medtronic transcatheter aortic valve implant system (corevalve system family) in the approved intended use. the main focus of this pms will be to generate additional information and report on all major adverse events up to 30 days from the day of implant procedure.

Eligibility criteria:
inclusion criteria: * patients with symptomatic heart disease due to severe native calcific aortic stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure and with anatomy appropriate for the 23, 26, 29 or 31 mm valve system who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy. * indications and contraindications are provided in the product instructions for use. * subject is scheduled to receive transcatheter aortic valve * subject is 18 years of age or older * the patient or his/her legally authorized representative (lar) has been informed about the nature of the pms and the informed consent for both audio visual (av) recording and for study participation has been obtained prior to performing any study-related procedures from the subject or legally authorized representative, as per applicable local requirements in india exclusion criteria: * none
removable devices in overjet reduction

Conditions: Skeletal Class II Malocclusion; Dental Overjet

Summary: the goal of this clinical trial si to compare two removable devices used to treat the mandibular retrusion in growing patients. the main questions it aims to answer are: * the efficacy of the two devices in the reduction of the overjet * the neuromuscolar effects developed on the stomatognatic system participants will be instructed in the use and maintenance of the devices and will be checked every 15-30 days for one year.


Eligibility criteria:
inclusion criteria: * skeletal class ii relationship, * complete eruption of upper first premolars * presence of unilateral or bilateral cross bite (falling within grade 3 iotn index). exclusion criteria: * iotn (index of orthodontic treatment need) index \> 4; * presence of epilepsy, * systemic disease, * tmd, or periodontal disease; * lack of written informed consent from a parent or legal guardian.
clc parent-child emotional preparation program

Conditions: Emotional Connection; Child Development; Primary Prevention; Disruptive Behavior

Summary: the purpose of this study is to investigate the feasibility of the nurture science program's (nsp) drop-in group via telemedicine as standard care at children's learning centers (clc) to prepare preschoolers emotionally for the preschool experience utilizing the welch emotional connection screen (wecs) relational health toolkit. the behavioral, neurobiological, and clinical insights gained from this project may lead to better treatment of emotional, behavioral and developmental disorders.

the purpose of this study is to test the practicality of mothers and children utilizing the wecs relational health toolkit. the cuddle and calm book, well baby book, mother and child mutual narrative activity card, bottle of feelings, mother's socioemotional support circle, and the wecs for emotional connection make up the preschool wecs relational health toolkit. the wecs relational health toolkit provides family-based resources to help mothers and children emotionally connect. the wecs relational health toolkit is designed to create emotional connection and establish mother-child autonomic co-regulation, which helps shape autonomic state and behavior of the mother and child and therefore determines early child development and mother well-being. the investigators will test whether this toolkit can be a positive part of a standard preschool education program. practicality will be measured through virtual participant attendance, a participant survey, and staff notes. effects of this program on the emotional connection of mother-child pair will be measured through the welch emotional connection screen (wecs). effects on child behaviors will be measured through the wecs-parent report (wecs-pr), sdq, and survey of wellbeing of young children baby pediatric symptom checklist (bpsc) or the preschool pediatric symptom checklist (ppsc) subscales (age-dependent). we will also measure symptoms of depression in the mothers using the center for epidemiological studies-depression (ces-d) before and after the introduction to the toolkit. we will also assess differences in developmental progress using the milestones subscale of the swyc.

Eligibility criteria:
inclusion criteria: - preschool aged children from 0-5 years old and their mothers in clc programs. exclusion criteria: - families that choose not to participate in any data collection procedures but would like to listen in on the session(s).

Keywords: welch emotional connection screen (wecs) toolkit nurture science program's (nsp) children's learning centers (clc) parent-child emotional preparation for preschool
accompanying alzheimer caregiver

Conditions: Alzheimer Disease

Summary: initiatives have been taken hotline in france and abroad for other conditions, they provide support to patients and their caregivers.

this is a descriptive pilot study, non-interventional, before / after, mono-centric, evaluative, prospective cohort with type score description. the tool used is the grid "mini zarit", she evaluates the caregiver burden. this grid is enabled in the french version and commonly used in these pathologies. the evaluation of the quality of life of the caregiver will be performed with the scale "eq-5d". this tool is easy to use phone, it contains few items. also there is very little evidence referring to the suffering or negative feelings. it therefore avoids inducing to helping unknown team consultation memory an emotionally negative discourse. there is no validated tool measuring the service delivered to a nurse hotline. the investigators offer a nurse questionnaire 7 items grouping expectations for the first consultation memory (consultation period, diagnosis, course of the consultation, organization of monitoring). it also provides an update on the daily experiences of the caregiver relative to the organization of care and helped the organization of domestic life of helped. nursing questionnaire will assess whether the responses of the nurse in relation to questions about the memory request for consultation were understood in relation to the items. also, if the caregiver is in support of application in everyday life, the questionnaire will determine if the nursing accompaniment allows the caregiver to acquire knowledge or skills, or better organization of everyday life. the question of the entourage of the caregiver assesses the isolation level of the caregiver and whether the environment is not mobilized or after an update with the nurse. if help is hospitalized, the pattern will be recovered. the scientific council will assess whether the information collected and the information provided would have prevented it.

Eligibility criteria:
inclusion criteria: * helping with age ≥ 18 years * helping speak and understand the french * help available to accompany the patient to the consultation * helping calling for the first time the memory center * helping who noticed a cognitive disorder in assisted * age over 75 years * beneficiary or affiliated to a social security scheme patient * patient with a cognitive disorder noticed by the caregiver exclusion criteria: * helping placed under judicial protection * any medical or paramedical personnel in connection with the care of a nursing home eligible patient (accommodation establishment for dependent elderly, hospital, ssr (care and rehabilitation services), institutional caregivers, * private health professionals, such as neighborhood (doctor, nurse liberal, physiotherapist * neighborhood.
copeptin after arginine infusion in polyuria-polydipsia syndrome

Conditions: Healthy; Polyuria-polydipsia Syndrome

Summary: the purpose of the study is to investigate whether arginine infusion is a new tool to differentiate patients with diabetes insipidus, primary polydipsia and healthy subjects.


Eligibility criteria:
inclusion criteria: 1. age over 18 years 2. no medication except hormonal contraception exclusion criteria: 1. evidence of any acute illness 2. subjects refusing or unable to give written informed consent 3. pregnancy 4. any evidence of disordered drinking habits and diuresis

Keywords: copeptin arginin stimulation test
mr compatible accelerometer for respiratory motion measurement

Conditions: Heart Disease

Summary: a novel magnetic resonance (mr) compatible accelerometer for respiratory motion sensing (marmot) has been developed as a surrogate of the vendors' pneumatic belts. the aim is to model and correct respiratory motion for free-breathing thoracic-abdominal mr imaging and to simplify patient installation.

respiratory motion is a serious problem in the acquisition of high-quality thoracic/abdominal magnetic resonance (mr) images. various methods have been proposed to compensate the motion-induced artefacts, including breathholding, respiratory gating and model-driven motion correction. breath-holding is the simplest among the three. however this conventional clinical method induces various problem, including inefficient use of scanners, inconsistent organ position between each breath-hold, imaging an altered physiological status and patient inconvenience especially for those who suffer from respiration difficulties. free-breathing mr acquisition has therefore become of great clinical interest recently. the investigators intend to examine the efficacy of the marmot sensors for: * modelling and predicting the respiratory motions in abdominal scans, * correcting for the respiratory motion in a cardiac cine scan, via a reconstruction-based method.

Eligibility criteria:
inclusion criteria: * to not have cardiac, hepatic or renal pathology * to be more than 18 * to be enrolled in a social security plan * to have signed an informed consent * to have preliminary medical examination exclusion criteria: * contraindication: implantable devices (pacemakers, defibrillators, cochlear implants, etc.), metallic foreign bodies * impossibility to undergo mri : claustrophobia, morbid obesity * pregnancy or risk of pregnancy * patient under a measure of legal protection

Keywords: mri motion respiratory movement artifacts correction
validation of a miniature spo2 sensor in healthy subjects and patients with long-term oxygen therapy.

Conditions: Pulse Oximeter Validation; Long Term Oxygen Therapy; Hypoxemia

Summary: by integrating a miniaturized pulse oximetry sensor into the frame of oxygen delivery glasses which dissimulates the nasal cannula, the investigators hope to optimize and long term oxygen therapy (ltot) regarding medical and social aspects. the validation of the novel spo2 sensor is the first step in the concept of personalized, dynamic delivery of oxygen by eyeglasses using a closed-loop system.

objectives: 1. to determine accuracy of spo2 measurements by the novel sensor compared to 2 reference pulse oximeters in healthy subjects undergoing a normobaric hypoxic challenge provoking spo2 desaturation. 2. to determine accuracy of spo2 measurements by the novel sensor compared to 2 reference pulse oximeters and to arterial blood gas analysis in patients qualifying for ltot, breathing room air at rest (lying, sitting, standing position) and during exercise (slow walking, 6-mwt, ergometer cycle).

Eligibility criteria:
healthy volunteers inclusion criteria: * age 18 - 60 years, * non smoker, * good general health and physical fitness * informed consent exclusion criteria: * current or history of tobacco smoking (\> 5 py) * current alcohol or drug abuse * heart disease or untreated arterial hypertension * pulmonary disease * epilepsy or other major neurologic disease * dark skin colour * known anemia * severe metabolic disease (e.g. diabetes) * pregnancy patients inclusion criteria: * age ≥ 18 years * long term oxygen therapy at rest and/or on physical effort * hypoxemia in arterial blood gas analysis at rest pao2 ≤ 55 mmhg or \ 174 g/l, women hb \> 140 g/l) or: oxygen desaturation on effort (spo2 \< 90%) * pulmonary disease including chronic obstructive pulmonary disease, interstitial lung disease and sarcoidosis * informed consent exclusion criteria: * severe hypoxemia (po2 \<40 mmhg) * severe hypercapnia (pco2 \>55 mmhg) * acute respiratory infection or systemic infection, * severe systolic heart disease (lvef \< 25%) * myocardial infarction during the last month before inclusion * unstable angina pectoris * severe aortic stenosis (mean gradient \> 40mmhg, valve area \<1 cm2) * rhythmogenic heart disease * severe or untreated arterial hypertension (blood pressure \> 180mmhg systolic, \>100mmhg diastolic) * anemia (hb \< 120 g/l) * known or suspected coagulation disorder (e.g. inr \> 4) * severe or untreated metabolic disorder * neurologic disease or dementia * pregnancy * history of non-compliance to medical treatment * current alcohol, drug abuse or current tobacco smoking * dark skin color
a study of pf-06647263 in patients with advanced solid tumors

Conditions: Neoplasms; Triple-Negative Breast Cancer

Summary: to assess the safety and tolerability at increasing dose levels of pf-06647263 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended phase 2 dose.

the clinical study will include 2 parts. part 1 will estimate the mtd in dose escalation cohorts in patients with advanced solid tumors for whom no standard therapy is available in order to establish the rp2d. part 2 will include patients with previously treated metastatic triple negative breast cancer (tnbc).

Eligibility criteria:
inclusion criteria: * diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available * performance status of 0 or 1 * adequate bone marrow, kidney, and liver function * part 2 includes advanced triple negative breast cancer patients. exclusion criteria: * brain metastases requiring steroids * major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start * active and clinically significant bacterial, fungal or viral infection

Keywords: adc pf-06647263 solid tumors tumors neoplasm metastasis tnbc triple negative breast cancer
study of talabostat and cisplatin in advanced melanoma

Conditions: Melanoma; Skin Cancer

Summary: the purpose of this study is to assess the antitumor activity and safety of the combination of talabostat and cisplatin in patients with metastatic melanoma.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed melanoma that is metastatic (unresectable stage iv per ajcc 2002) * patients with measurable disease defined as at least one measurable index lesion with clearly defined margins * ecog performance status of 0, 1, or 2 * expected survival ≥12 weeks * written informed consent exclusion criteria: * more than 1 prior chemotherapy or biotherapy regimen for metastatic melanoma * radiation therapy to \>50% of the bone marrow. patients must not have had prior radiotherapy to index lesions unless they have clearly progressive disease in this site or there is measurable disease outside the area of prior radiation. * clinically significant laboratory abnormalities * symptomatic cns metastases * any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix * the need for chronic (i.e., \>7 days) oral or intravenous corticosteroid therapy * any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol * patients who are within 30 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for melanoma. patients must have recovered from all of the side effects of treatment in order to be enrolled. * pregnant or lactating women.